TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT

K021287 · Medtronic Perfusion Systems · DTN · May 7, 2002 · Cardiovascular

Device Facts

• Record ID: K021287
• Device Name: TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
• Applicant: Medtronic Perfusion Systems
• Product Code: DTN · Cardiovascular
• Decision Date: May 7, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trillium™ AFFINITY NT CVR with Trillium BoPassive Surface is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures

Device Story

Hardshell collection reservoir for venous and cardiotomy suctioned blood during cardiopulmonary bypass. Blood enters through top, passes through filter media; design minimizes contact with open-cell polyurethane defoamer when operating volume is <1000ml and no foaming occurs. Features Trillium BioPassive surface coating on blood-contacting pathways to improve biocompatibility. Used in clinical perfusion settings by perfusionists/clinicians. Output is collected blood volume for return to circulation. Benefits include reduced blood-material interaction via surface modification.

Clinical Evidence

No clinical data. Substantial equivalence supported by biocompatibility and in vitro bench testing comparing the subject device to predicate devices.

Technological Characteristics

Hardshell reservoir; blood-contacting surfaces coated with Trillium Biopassive Surface; open-cell polyurethane defoamer; filter media. No new materials or manufacturing processes compared to predicate, excluding the surface coating.

Indications for Use

Indicated for use in extracorporeal perfusion circuits to collect venous and cardiotomy suctioned blood during cardiopulmonary bypass procedures. No specific patient population age or gender restrictions provided.

Regulatory Classification

Identification

A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

Special Controls

*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• AFFINITY Cardiotomy Venous Reservoir (K936003)
• AFFINITY Hollow Fiber Oxygenator with Trillium Biopassive Surface (K973760)

Submission Summary (Full Text)

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K021287

# SUMMARY OF SAFETY AND EFFECTIVENESS

# COMPANY AND CONTACT PERSON

Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 [phone] Tel: FAX: [phone]

Preeti Jain, Senior Manager, Regulatory/Clinical Affairs

### DEVICE NAME

Trillium™ AFFINITY NT CVR with Filter with Trillium BioPassive Surface

# name of predicated or legally marketed device

AFFINITY Cardiotomy Venous Reservoir (K936003) Al TiNTT | Oardlotomy vonous with Trillium™ Biopassive Surface (K973760)

### DESCRIPTION OF DEVICE

The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is a hardshell collection reservoir for venous blood and for blood recovered from Cardiotomy ouction room of for renease ices. The blood recovered by intracardiac suction ouslow and venthoular devices enters the reservoir through the top and passes through a filter media. The design of the reservoir is such that if, under normal operating a lume of less than 1000ml and if there is no foaming of the recovered blood, there is no blood contact with the open cell polyurethane defoamer. Venous there to ho blood comugh the top of the reservoir and is mixed with the filtered blood. As with the recovered Cardiotomy blood, under normal operating volume of less than 1000ml if there is no foaming of the venous blood entering the reservoir, there is no blood contact with the defoamer.

## STATEMENT OF INTENDED USE

The Trillium™ AFFINITY NT CVR with Trillium BoPassive Surface is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures

# STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE

The AFFINITY Cardiotomy/Venous Reservoir is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures

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# STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".

### DETERMINATION OF SUBSTANTIAL EQUIVALENCE

This "SPECIAL 510(k)" is being submitted for a modification to the AFFINITY Cardiotomy/Venous Reservoir. The modification to the currently marketed Cardiotomy/Venous Reservoir : "The mounted surfaces with Trillium"".

The Trillium™ AFFINITY NT CVR is being compared to the following marketed devices:

- AFFINITY Cardiotomy Venous Reservoir (K936003) .
- AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)

The Trillium™ AFFINITY NT CVR has the same indications statement and intended uses as the:

- AFFINITY Cardiotomy Venous Reservoir (K936003) .
The Trillium™ AFFINITY NT CVR has "no new technological characteristics (e.g., materials and manufacturing processes)" from the currently marketed Cardiotomy/Venous Reservoir. The technological characteristic is solely the coating material of the blood pathway:

- Trillium™ .
The technological characteristic of the Trillium™ Biopassive Surface is common to other medical devices (hollow fiber oxygenators) currently in commercial distribution as follows:

- AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)
This technological characteristic "could affect the safety and effectiveness of the device". However, these "technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics".

"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the Trillium" AFFINITY NT CVR is substantially equivalent to other marketed extracorporeal cardiopulmonary bypass devices.

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The biocompatibility and in vitro bench testing demonstrated that when compared to the
predicate devices, the Trillium" AFFINITY NT CVR does not significantly affect safety and effectiveness and is substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices.

1. September 19.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 7 2002

Mr. Preeti Jain Senior Manager, Regulatory/Clinical Affairs Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428

Re: K021287

> Trade Name: Trillium™ AFFINITY NT Cardiotomy Venous Reservoir Regulation Number: 21 CFR 840.4400 Regulation Name: Cardiotomy Reservoir Regulatory Class: II (two) Product Code: DTN Dated: April 22, 2002 Received: April 23, 2002

Dear Mr. Jain:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can . be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Preeti Jain

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter with are in your e FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

Trillium™ AFFINITY NT Cardiotomy Venous Reservoir Device Name:

#### Indications for Use:

The Trillium™ AFFINITY NT CVR with Trillium BioPassive Surface is indicated for use in the extracorporeal perfusion circuit to collect venous and Cardiotomy suctioned blood during cardiopulmonary bypass procedures.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter use

Division of Cardiovascular & Respiratory Devices
510(k) Number K031287